D-Glucopyranose, oligomeric, heptyl glycosides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-23 Mar 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe interministeriel des produits chimiques, Ivry sur Seine, France

Test material

Test material information

Constituent 1

Reference substance name:

(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol

EC Number:

807-654-3

Cas Number:

1627851-18-6

Molecular formula:

(C6H10O5)nC7H16O, n - number of D-glucopyranose units

IUPAC Name:

(2R,3R,4S,5S,6R)-2-(heptyloxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2R,3R,4S,5S,6R)-2-{[(2R,3S,4S,5R,6R)-6-{[(2R,3S,4S,5R,6R)-6-(heptyloxy)-3,4,5-trihydroxyoxan-2-yl]methoxy}-3,4,5-trihydroxyoxan-2-yl]methoxy}-6-(hydroxymethyl)oxane-3,4,5-triol

Test material form:

other: solid, not further specified

Details on test material:

- Name of test material (as cited in study report): Heptylglucoside
- Physical state: solid
- Analytical purity: < 99% dry matter
- Lot/batch No.: 3675 JG
- Expiration date of the lot/batch: 16/01/2016
- Storage condition of test material: room temperature

Test animals

Species:

human

Strain:

other: SkinEthic model, in vitro human reconstructed epidermis

Details on test animals or test system and environmental conditions:

TEST SKIN MODEL
- Source: SkinEthic, Lyon, France

TEST METHOD
Skin Ethic RHE/S/17:
0.5 cm² reconstructed epidermis of normal human keratinocytes. Cells are grown on inert polycarbonate filter on chemically defined medium, airlifted for 17 days. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.

ADAPTATION TO CELL CULTURE CONDITIONS
Upon receipt, tissues were transferred into 6-well plates containing 2 mL of growth medium in a humidified incubator for at least 1 h (37 ± 1 °C, 5% CO2) before use.

INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37
- CO2 gas concentration (%): 5
- Humidity: saturated

Test system

Type of coverage:

open

Preparation of test site:

other: Intact reconstructed epidermis

Vehicle:

other: PBS

Controls:

other: concurrent control tissues treated with PBS served as negative controls, positive controls were exposed to 5% SDS.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 ± 2 mg

POSITIVE CONTROL SUBSTANCE:
- Positive control substance: SDS, 5 % (v/v), 16 ± 0.5 µL

Duration of treatment / exposure:

42 ± 1 min

Observation period:

Not applicable. Post-treatment incubation period: 42 ± 1 h.

Number of animals:

Not applicable. The test was performed in triplicates for each treatment and control group.

Details on study design:

TEST SITE
- Area of exposure: 0.5 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: the test item was washed from the epidermises with phosphate buffered saline.
- Time after start of exposure: 42 ± 1 min
- Post-treatment incubation period: 42 ± 1 h

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: cell viability (%)

Value:

100

Remarks on result:

other:

Remarks:

Basis: other: mean value of negative controls (PBS). Time point: 42 min exposure, 42 h incubation. Reversibility: other: not applicable. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: cell viability (%)

Value:

114.8

Remarks on result:

other:

Remarks:

Basis: other: mean value of test item (pure). Time point: 42 min exposure, 42 h incubation. Reversibility: other: not applicable. (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: cell viability (%)

Value:

2.9

Remarks on result:

other:

Remarks:

Basis: other: mean values of positve control (SDS, 5%). Time point: 42 min exposure, 42 h incubation. Reversibility: other: not applicable. (migrated information)

Any other information on results incl. tables

Table 1: MTT assay after 42 min exposure, 42 h incubation exposure

	Negative control			Positive control			Test item			Dead Ep.
Tissue sample	1	2	3	1	2	3	1	2	3
OD540	1.503 1.512 1.533	1.321 1.308 1.321	1.405 1.400 1.414	0.031 0.035 0.033	0.042 0.044 0.045	0.046 0.047 0.049	1.877 1.893 1.903	1.613 1.611 1.623	1.562 1.564 1.579	0.083 0.064 0.060
OD540(mean)	1.516	1.317	1.406	0.033	0.044	0.047	1.891	1.616	1.568	0.069
OD540(mean values of replicates)	1.413			0.041			1.692			0.069
Viability (%)	100			2.9			119.7			4.9

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified